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Improving Executive Functioning After Traumatic Brain Injury (TBI): A Trial of the "Short Term Executive Plus" Program (STEP)

Primary Purpose

Traumatic Brain Injury

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Immediate Start
Waitlist
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury focused on measuring Brain Injuries, Cognitive Rehabilitation, Executive Functioning

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Be 18 years old or older;
  • Having a TBI as a result of a blow to the head followed by a loss of consciousness or period of being dazed and confused or a period of post traumatic amnesia or clinical signs of altered neurological function; this information must be medically documented (e.g., emergency medical record, hospital record, neuroradiological report, or neurological exam or record of physician's visit within 24 hours of injury);
  • Being at least three months post-injury;
  • Being English-speaking (treatment sessions will be conducted in English);
  • Reporting executive dysfunction (by self or family);
  • Being willing and able to participate in and travel to the program daily for three months;
  • Being oriented to time, place and person;
  • Having a full-scale IQ of at least 75;
  • Having a score on the Galveston Orientation and Amnesia Test of 75 or more;
  • Having communication skills adequate to participate in groups;
  • Having at least a sixth-grade reading level (for testing and use of written materials);
  • Being willing to complete questionnaires and interviews about mood, thinking skills, participation and the like; AND
  • Agreeing to participate, i.e., completion of informed consent and HIPAA documents.

Exclusion Criteria:

  • Have diminished mental capacity and as a result, are unable to sign informed consent;
  • Active substance abuse;
  • Active psychosis;
  • Active suicidality;
  • Disruptive or violent behavior to self or others;
  • Current cognitive rehabilitation (this will not include current psychotherapy);
  • No impairment on the FRSBE or WCST; OR
  • Showing evidence of or a diagnosis of dementia or mild cognitive impairment.

Sites / Locations

  • Icahn School of Medicine at Mount Sinai

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Immediate start

Waitlist group

Arm Description

Starts the 12 week intervention immediately after enrollment

Starts the 12 week intervention 12 weeks after initial enrollment

Outcomes

Primary Outcome Measures

Executive functioning
Executive functioning
Executive functioning
Executive functioning
Executive functioning

Secondary Outcome Measures

Attention
Attention
Attention
Attention
Attention
Depression and anxiety
Depression and anxiety
Depression and anxiety
Depression and anxiety
Depression and anxiety
Memory and learning
Memory and learning
Memory and learning
Memory and learning
Memory and learning
Participation, life satisfaction, and self-efficacy
Participation, life satisfaction, and self-efficacy
Participation, life satisfaction, and self-efficacy
Participation, life satisfaction, and self-efficacy
Participation, life satisfaction, and self-efficacy

Full Information

First Posted
February 20, 2008
Last Updated
September 23, 2013
Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
Centers for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT00627237
Brief Title
Improving Executive Functioning After Traumatic Brain Injury (TBI): A Trial of the "Short Term Executive Plus" Program
Acronym
STEP
Official Title
Short-Term Executive Plus (STEP): A Randomized Controlled Trial of Short Term Intensive Cognitive Rehabilitation.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
Centers for Disease Control and Prevention

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine the efficacy of an intensive short term cognitive rehabilitation program aimed towards improving executive functioning in individuals with traumatic brain injury (TBI).
Detailed Description
Executive dysfunction following brain injury (BI) is commonly observed and has been well documented in the literature (Mateer, 1999; Prigatano, 1999; Levine et al., 2000; Shallice & Burgess, 1991; Cicerone & Giacino, 1992; Goldman-Rakic, 1993; Lezak, 1995, Riegal & Gauggel, 2002; McDonald, 2002; Stuss and Levine, 2003). Level of functioning such as vocational success, community reintegration, and social autonomy are associated with executive functioning abilities following BI (Mazaux et al. 1997, Sohlberg, Mateer, & Stuss, 1993; (Stuss & Levine, 2002, McDonald, 2002). Studies describing the rehabilitation of executive dysfunction have been limited to mostly single case or small group designs (Cicerone, et al., 2000). However, there have been three small randomized clinical trials that have had promising results suggesting the need for more research in this area. When considering all of the studies, it is evident that emphasis has been placed on three areas of intervention: attention remediation, emotional regulation and problem-solving. Consequently, given the pervasive disability found in individuals with BI that is secondary to executive function disorders and the promising, but limited, success of problem-solving-based interventions for executive functions, a randomized controlled trial (RCT) of the efficacy of a short-term, intensive executive function training program (Short-Term Executive Plus) is proposed. The Short-Term Executive Plus (STEP) program will combine treatments and treatment approaches that have proved to be effective in previous studies and will be compared to "wait-list" control group. This design was chosen because no appropriate control intervention exists. In other words there is no "standard" rehabilitation treatment available to these individuals that could serve as an appropriate "control" condition/treatment. As discussed earlier, cognitive remediation is typically delivered in extended full-time day treatment programs or weekly/bi-weekly individual sessions. Using more traditional extended treatments as a control condition would be inappropriate, as persons who can participate in extended, full-time are not the target of the proposed intervention. It is hypothesized that the STEP program will result in significant improvements in executive functioning (and related areas of attention, memory, community participation, and life satisfaction).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
Keywords
Brain Injuries, Cognitive Rehabilitation, Executive Functioning

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immediate start
Arm Type
Experimental
Arm Description
Starts the 12 week intervention immediately after enrollment
Arm Title
Waitlist group
Arm Type
Experimental
Arm Description
Starts the 12 week intervention 12 weeks after initial enrollment
Intervention Type
Behavioral
Intervention Name(s)
Immediate Start
Intervention Description
Participation in an intensive cognitive rehabilitation program 3 days a week (3 hours a day) for 12 weeks. Each day consists of a 50 minutes of problem solving group, 50 minutes of individualized attention training, and a 50 minute emotional regulation group session with 10 minutes breaks between each module.
Intervention Type
Behavioral
Intervention Name(s)
Waitlist
Intervention Description
Participation in an intensive cognitive rehabilitation program 3 days a week (3 hours a day) for 12 weeks. Each day consists of a 50 minutes of problem solving group, 50 minutes of individualized attention training, and a 50 minute emotional regulation group session with 10 minutes breaks between each module.
Primary Outcome Measure Information:
Title
Executive functioning
Time Frame
At the beginning of the intervention
Title
Executive functioning
Time Frame
At 12 weeks
Title
Executive functioning
Time Frame
At 24 weeks
Title
Executive functioning
Time Frame
At 6 months
Title
Executive functioning
Time Frame
At 1 year post-intervention.
Secondary Outcome Measure Information:
Title
Attention
Time Frame
At the beginning of the intervention
Title
Attention
Time Frame
At 12 weeks
Title
Attention
Time Frame
At 24 weeks
Title
Attention
Time Frame
At 6 months
Title
Attention
Time Frame
At 1 year post-intervention
Title
Depression and anxiety
Time Frame
At the beginning of the intervention
Title
Depression and anxiety
Time Frame
At 12 weeks
Title
Depression and anxiety
Time Frame
At 24 weeks
Title
Depression and anxiety
Time Frame
At 6 months
Title
Depression and anxiety
Time Frame
At 1 year post-intervention
Title
Memory and learning
Time Frame
At the beginning of the intervention
Title
Memory and learning
Time Frame
At 12 weeks
Title
Memory and learning
Time Frame
At 24 weeks
Title
Memory and learning
Time Frame
At 6 months
Title
Memory and learning
Time Frame
At 1 year post-intervention
Title
Participation, life satisfaction, and self-efficacy
Time Frame
At the beginning of the intervention
Title
Participation, life satisfaction, and self-efficacy
Time Frame
At 12 weeks
Title
Participation, life satisfaction, and self-efficacy
Time Frame
At 24 weeks
Title
Participation, life satisfaction, and self-efficacy
Time Frame
At 6 months
Title
Participation, life satisfaction, and self-efficacy
Time Frame
At 1 year post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Be 18 years old or older; Having a TBI as a result of a blow to the head followed by a loss of consciousness or period of being dazed and confused or a period of post traumatic amnesia or clinical signs of altered neurological function; this information must be medically documented (e.g., emergency medical record, hospital record, neuroradiological report, or neurological exam or record of physician's visit within 24 hours of injury); Being at least three months post-injury; Being English-speaking (treatment sessions will be conducted in English); Reporting executive dysfunction (by self or family); Being willing and able to participate in and travel to the program daily for three months; Being oriented to time, place and person; Having a full-scale IQ of at least 75; Having a score on the Galveston Orientation and Amnesia Test of 75 or more; Having communication skills adequate to participate in groups; Having at least a sixth-grade reading level (for testing and use of written materials); Being willing to complete questionnaires and interviews about mood, thinking skills, participation and the like; AND Agreeing to participate, i.e., completion of informed consent and HIPAA documents. Exclusion Criteria: Have diminished mental capacity and as a result, are unable to sign informed consent; Active substance abuse; Active psychosis; Active suicidality; Disruptive or violent behavior to self or others; Current cognitive rehabilitation (this will not include current psychotherapy); No impairment on the FRSBE or WCST; OR Showing evidence of or a diagnosis of dementia or mild cognitive impairment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wayne Gordon, Ph.D.
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029-6574
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23988395
Citation
Cantor J, Ashman T, Dams-O'Connor K, Dijkers MP, Gordon W, Spielman L, Tsaousides T, Allen H, Nguyen M, Oswald J. Evaluation of the short-term executive plus intervention for executive dysfunction after traumatic brain injury: a randomized controlled trial with minimization. Arch Phys Med Rehabil. 2014 Jan;95(1):1-9.e3. doi: 10.1016/j.apmr.2013.08.005. Epub 2013 Aug 27.
Results Reference
derived

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Improving Executive Functioning After Traumatic Brain Injury (TBI): A Trial of the "Short Term Executive Plus" Program

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